Archive | Regulatory

FDA Grants Fast Track Designation to Nemvaleukin Alfa for Mucosal Melanoma

Nemvaleukin alfa (Nemvaleukin) has been granted fast-track designation by the FDA for the treatment of patients with mucosal melanoma who have received prior treatment with an anti–PD-L1 therapy, according to a press release from Alkermes.1

Read the full story

Posted in Melanoma News, Regulatory, Publications

FDA Sets PDUFA Date for Pembrolizumab

Merck announced that its phase 3 KEYNOTE-716 (NCT03553836) trial investigating pembrolizumab (Keytruda) has met its primary endpoint…

Read the full story

Posted in Melanoma News, Regulatory, Publications

FDA Grants Orphan Drug Designation to Alrizomadlin for Stage IIB-IV Melanoma

The FDA has granted an orphan drug designation to alrizomadlin (APG-115) as a potential therapeutic option for patients with stage IIB-IV melanoma, according to an announcement from Ascentage Pharma, the drug developer.1

Read the full story

Posted in Melanoma News, Regulatory, Publications

FDA Grants Orphan Drug Designation to Cavrotolimod for Merkel Cell Carcinoma

The FDA has granted an orphan drug designation to cavrotolimod (AST-008) for the treatment of patients with Merkel cell carcinoma (MCC), according to an announcement from Exicure, Inc.1

Read the full story

Posted in Melanoma News, Regulatory, Publications